FDA 510(k) Application Details - K152808

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K152808
Device Name	Syringe, Antistick
Applicant	U&U Medical Technology Co., Ltd Dongzhou Village, Hengshanqiao Changzhou 213119 CN Other 510(k) Applications for this Company
Contact	Black Wang Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2015
Decision Date	03/25/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review